Efficiency of Two Maxillary Expanders for Maxillary Arch Expansion in Bilateral Cleft Lip and Palate Patients

Ain Shams University

Status: Completed

Conditions: Bilateral Cleft Lip and Palate; Maxillary Expansion

Treatments: Device: 3D Maxillary Expansion using modified Fan expander with springs; Device: 3D Maxillary Expansion with 3 expansion screws

Study type: Interventional

Funder types: Other

Identifiers

NCT07056296

FDASU-Rec ID 052316

Details and patient eligibility

About

This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft

Full description

The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.

Enrollment: 20 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with age ranging from 8 to 15 years old.
• Patients with bilateral cleft lip and palate.
• Patients with repaired cleft lip and / or palate.
• Patients with fully erupted upper permanent 1st molars.
• Patients in the late mixed or early permanent dentition with tapered maxillary arch, requiring palatal expansion as part of their treatment.
• Patient's stage of cervical vertebral maturation before or at the growth spurt (CS1-CS4).

Exclusion criteria

• Patients with syndromic cleft lip and palate.
• Patients with very bad oral hygiene and active periodontal disease.
• Vulnerable groups

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Three-way iMini Hyrax group

Experimental group

Description:

For group (A) cases, a custom-made Three-way palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. Three mini-expansion screws with two break resistant retention legs, oriented as follows: a transverse screw and bilateral sagittal screws.

Treatment:

Device: 3D Maxillary Expansion with 3 expansion screws

Fan Expander group

Active Comparator group

Description:

For group (B) cases, a custom-made modified Fan palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. A fan expansion screw with break resistant retention legs with soldered finger springs just palatal to the premaxilla.

Treatment:

Device: 3D Maxillary Expansion using modified Fan expander with springs